MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS HI FLEX ISRT SZ 3-4 13; PROST, KNEE, PATFEMTIB, SEMI-CONSTRAIN, CEMENT, POLY/MET/POLY

Model Number 71421510

Device Problem Material Separation (1562)

Patient Problem Injury (2348)

Event Date 01/07/2020

Event Type  Injury  

Event Description

It was reported that revision surgery was performed because it was suspected fracture of the insert and disassociation, but the insert was not fractured and disassociated.

• Brand Name: GII PS HI FLEX ISRT SZ 3-4 13
• Type of Device: PROST, KNEE, PATFEMTIB, SEMI-CONSTRAIN, CEMENT, POLY/MET/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9615843
• MDR Text Key: 175877968
• Report Number: 1020279-2020-00363
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 03596010492920
• UDI-Public: 03596010492920
• Combination Product (y/n): N
• PMA/PMN Number: K032295
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/29/2014
• Device Model Number: 71421510
• Device Catalogue Number: 71421510
• Device Lot Number: 04GM03223
• Date Manufacturer Received: 12/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 71420166, 05ET89778, GNS II CMT TIB SIZE 4 LEFT; 71420166, 05ET89778, GNS II CMT TIB SIZE 4 LEFT
• Patient Outcome(s): Hospitalization; Required Intervention